Kornimate/medical-research-clean huggingface dataset:
a study of prt-201 administered immediately after arteriovenous fistula creation in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to determine if prt-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. prt-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in avf patients in a previous study.


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years. 2. life expectancy of at least 6 months. 3. chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months. 4. planned creation of a new radiocephalic or brachiocephalic avf. revisions of an existing avf and transposed avf are not acceptable. exclusion criteria: 1. history or presence of an arterial aneurysm. 2. malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ. 3. hepatic dysfunction defined as bilirubin, alt \[sgpt\] or ast \[sgot\] \>2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices. 4. treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Keywords: arteriovenous fistula avf hemodialysis vascular access dialysis fistula prt-201 vonapanitase kidney renal
evaluation of the mp diagnostics htlv blot 2.4

Conditions: HTLV-I Infections; HTLV-II Infections; Human T-lymphotropic Virus 1; Human T-lymphotropic Virus 2; HTLV I Associated T Cell Leukemia Lymphoma; HTLV I Associated Myelopathies

Summary: the purpose of this study is: 1. to assess the validity and reproducibility of the mp diagnostics htlv blot 2.4. 2. to conduct a sensitivity analysis of the htlv blot 2.4 using a known positive population.

this is a retrospective study designed to assess the validity and reproducibility of the mp diagnostics ivd device, the htlv blot 2.4 (mp blot), in various populations. the study will be conducted at three geographical distinct locations. the validity of the mp blot will be assessed by calculating the following: 1. percent negative agreement with cdphl algorithm on 200 eia negative specimens 2. percent positive agreement with cdphl algorithm on 200 eia repeat reactive specimens the sensitivity of the mp blot will be evaluated by testing 200 known positive specimens. the study will be performed using three product lots at three clinical sites. the reproducibility of the mp blot will be assessed by testing two replicates of a three member panel at three clinical testing sites with each of three lots of product over multiple days by three operators.

Eligibility criteria:
inclusion criteria: * eia negative population 1. male or female 2. completion of a health history evaluation for routine donor screening 3. willing and able to provide informed consent 4. negative screening assay results for all arc screening assays * eia repeat reactive population 1. male or female 2. completion of a health history evaluation for routine donor screening 3. willing and able to provide informed consent 4. previous rr result by biomerieux elisa, abbott eia, and / or abbott chlia prism * known positive population 1. male or female 2. willing and able to provide informed consent 3. previous reactive screening test using either the biomerieux elisa, the abbott eia or the abbott chlia prism, followed by supplemental testing exclusion criteria: * eia negative population 1. inadequate sample volume for testing 2. unable to provide samples that meet the sample suitability requirements for testing 3. positive screening result for any infectious disease tested by arc * eia repeat reactive population 1. inadequate sample volume for testing 2. unable to provide samples that meet the sample suitability requirements for testing 3. positive result for hiv, hbv, hcv, or any other infectious disease * known positive population 1. unwilling or unable to provide informed consent 2. unable to provide adequate sample volume for testing 3. unable to provide samples that meet the sample suitability requirements for testing 4. positive result for hiv

Keywords: htlv confirmatory supplemental blot htlv-i htlv-ii
become children of holders corpus callosum agenesis screened in period antenatal

Conditions: Corpus Callosum Agenesis

Summary: the corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the general population. this malformation is mostly diagnosed prenatally by ultrasound, usually at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple. several studies in recent years have helped to define the determinants of prognosis for the unborn child suffers from agenesis of the corpus callosum, whether total or partial. these, mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning or viral seroconversion when pregnancy) is associated with favorable developments in terms of psychomotor development in 80% of cases similar results were also found in prospective studies, while the associated nature of the defect seems most heavily encumber the prognosis as other malformation or syndrome associated with agenesis of the corpus callosum although these recent data have already significantly influence prenatal counseling and outcome of pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis of the corpus callosum are still valid.


Eligibility criteria:
inclusion criteria: * children born between january 2000 and january 2013 carrying a corpus callosum agenesis detected prenatally via the multidisciplinary center for prenatal diagnosis (cpdpn) of the alsace-lorraine region, * children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes exclusion criteria: * children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes

Keywords: corpus callosum agenesis agenesis corpus callosum
covid-19 airway management

Conditions: Covid-19_airways Management

Summary: the study has a retrospective and a prospective component. the retrospective component aims to review data of all airway management related saes in covid 19 patients (between april and july 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. the prospective component aims to assess the incidence of covid-19 infection in airway management team members by means of an interview assessing their covid19 status after participating in airway management in the period outlined above. this prospective interview component is starting in december 2020.

approximately 5-10% of all patients affected by covid-19 develop severe respiratory distress. this has already involved hundreds of people in ontario and thousands worldwide. in this situation, support with a mechanical ventilator is required. the first essential step to provide this support is to insert a breathing tube in the patent's trachea (windpipe), a process called 'endotracheal intubation' or more broadly, 'airway management'. while a fundamental lifesaving resource, endotracheal intubation in covid-19 patents is a highly specialized procedure that carries risk both to patents and attending healthcare providers as follows. a) clinicians involved in airway management for patients with coronaviruses are at extremely high risk of infection due to aerosol and droplet exposure during the procedure. b) rapid administration of drugs that put the patent to sleep is usually required for prompt and safe endotracheal intubation. however, in physiologically compromised patents, life-threatening side-effects may occur, such as very low oxygen levels (in as many as 70% of patients), low blood pressure (18-22% of patients), and cardiac arrest (2%); these can significantly affect outcomes. no definitive data are presently available to accurately quantify the risk posed by such procedures to healthcare professionals and patents, nor the associated factors. we have developed a retrospective study reviewing data all airway management related saes in covid 19 patients (between april and july 2020); hypoxemia, hypotension and cardiac arrest within 15 min of intubation. additionally, we are going to prospectively interview airway management team members that were involved in the airway management of covid19 patients in the period described above, in order to assess whether they developed signs and symptoms and/or a confirmed covid19 infection. this prospective interview component is starting in december 2020.

Eligibility criteria:
inclusion criteria: all suspected or confirmed covid-19 patients that require intubation health care workers from the airways management team who performed an intubation on confirmed or suspected covid-19 patients exclusion criteria: lack of health care provider consent
patient outcomes and gingival blood flow using laser doppler flowmetry following the use of episil on free gingival graft donor sites

Conditions: Pain From Free Gingival Graft

Summary: the hypothesis for the present study is that patient-based outcomes and gingival blood flow will be more favorable for the free gingival graft (fgg) donor sites being covered by the test wound dressing material episil compared to the control dressing.


Eligibility criteria:
inclusion criteria: * patient of record at uthealth school of dentistry houston texas * signed treatment plan for a fgg * the ability to provide research informed consent exclusion criteria: * any allergies to any of the ingredients in episil including allergies to peanuts, soy or peppermint oil * smokers * pregnant or breast feeding women * inability or unwillingness to provide informed consent
effect of addition of steroids on duration of analgesia

Conditions: Uterine Fibroids; Adenomyosis

Summary: the purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a superior hypogastric nerve block (shnb) with and without corticosteroid performed as part of the uterine artery embolization (uae) procedure.

investigators will enroll a total of 28 women undergoing the uae procedure with 14 subjects in each study arm. this investigation is a single blind randomized control trial investigating the post-procedural analgesic effect of adding a corticosteroid (triamcinolone) as an adjuvant to a shnb that contains bupivacaine for patients undergoing uae, compared to patients undergoing nerve block for pain control following uae with local anesthetic only. before and after the procedure, patients will be asked to complete online surveys in order to record their pain score (measured on the visual analog pain scale), opioid and other pain medication use, and other symptoms, such as nausea.

Eligibility criteria:
inclusion criteria: * females * aged between 30 and 60 years * diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo uae procedure exclusion criteria: * contraindications to uae * shnb is deemed unsafe for the patient * allergies to local anesthetic or steroid agent * history of inflammatory bowel disease or ulcerative colitis * uncorrectable abnormal coagulation profile * diabetes mellitus

Keywords: uterine artery embolization
investigation of the effect of custom made insoles on foot pressure distribution and gait parameters in patients with morton's neuroma

Conditions: Morton Neuroma

Summary: the aim of our study is to investigate the effect of the use of custom made insoles in the treatment of morton's neuroma on foot pressure, temporal and spatial gait parameters.


Eligibility criteria:
inclusion criteria: * diagnosis of unilateral morton neuroma * confirmation of the diagnosis of morton's neuroma with magnetic resonance imaging (mri) * pain level of the patients while walking is at least 3 according to the visual analogue scale (vas). * volunteer to work exclusion criteria: * symptomatic musculoskeletal disease in the lower extremity * peripheral nervous system disease * presence of rigid deformity in the foot * extremity or contralateral extremity surgery with morton's neuroma
evaluation of latanoprost combined with fractional erbium- yag laser

Conditions: Alopecia Areata

Summary: alopecia areata (aa) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss. clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population. the exact pathobiology of aa has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. multiple genetic, environment factors and psychological stress contribute to the pathogenesis of alopecia areata . recent insights into the pathogenesis of aa have led to the development of new treatment strategies, such as janus kinase inhibitors, biologics and several small molecular agents. in addition, modern therapies for aa, including antihistamines, platelet-rich plasma injection

latanoprost is a prostaglandin analogue with well-established efficacy in the treatment of open-angle glaucoma and ocular hypertension. make an increase in the number, thickness and length of eyelashes is an important side effect of latanoprost eye drop. this study aimed to evaluate the effect of hypertrichosis property of latanoprost in the treatment of scalp alopecia areata. numerous techniques and agents such as microneedling, dermabrasion, radiofrequency and lasers have been used to increase penetration within an approach known as transdermal drug delivery. one of these techniques is laser-assisted drug delivery (ladd), which often uses ablative fractional lasers (co2 or erbium: yag lasers) because of their capacity to produce microscopic ablated channels. ladd is a promising technique that enhances the absorption of topical molecules while adding the synergic effect. microneedling is a form of therapy that utilizes instruments that contain rows of thin needles that penetrate the dermis to uniform depth, creating a controlled skin injury. transcutaneous drug delivery via fractional laser and microneedling is a promising modality with preliminary evidence for increased hair regrowth over topical therapy alone. trichoscopy is a noninvasive procedure performed in dermatology clinics and is a helpful tool in determining the correct diagnosis of hair loss presentations. the five most characteristic trichoscopic findings in aa are yellow dots, black dots, broken hairs, short vellus hairs and tapering hairs. also trichoscopy is a useful tool that allows monitoring of response during treatment of aa.

Eligibility criteria:
inclusion criteria: * patients of both sexes with localized stable alopecia areata of the scalp of 3 months duration at least. exclusion criteria: 1. acute or chronic infections. 2. pregnant or lactating women. 3. scarring alopecia. 4. alopecia totalis , alopecia universalis and ophiasis. 5. autoimmune dermatological diseases.
effectiveness of glucose control, β cell function in response to short-term insulin pump therapy in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic control.


Eligibility criteria:
inclusion criteria: different course of type 2 diabetes with poor glycemic control - exclusion criteria: * acute complication or severe comorbidities
gene mutations in patients with advanced prostate cancer that is not responsive to hormone therapy

Conditions: Prostate Cancer

Summary: rationale: gene mutations may make prostate cancer cells unable to attach to androgens. this may permit the growth of prostate cancer. gene testing may improve the identification of patients with advanced prostate cancer. purpose: clinical trial to study the androgen receptor gene in patients with prostate cancer that is not responsive to hormone therapy.

objectives: 1. the feasibility of collecting bone marrow biopsies from prostate cancer patients in a cooperative group setting 2. the incidence of marrow invasion by prostate tumor in random bone marrow biopsy 3. the influence of previous prostate radiation on obtaining prostate tumor 4. the frequency and type of ar mutations and 5. association of ar mutations with response to antiandrogen withdrawal.

Eligibility criteria:
1. histologically proven adenocarcinoma of the prostate that is refractory to hormone therapy 2. patients who are eligible for anticancer therapy on protocol clb-9480, clb-9583, clb-9680, or clb-9780 are also eligible for this study if they have not started treatment on those protocols

Keywords: adenocarcinoma of the prostate recurrent prostate cancer
adhesive strips vs sutures in skin closure for lumbar spinal fusion

Conditions: Surgical Site Infections; Lumbar Spinal Fusion

Summary: comparison between two methods for skin closure in lumbar spinal fusion surgery, a non-inferiority approach between sutures and adhesive strips and its effect on surgical site infections.

surgical site infections (ssis) are among the most common complications in spine surgery, the average rate of infection in spine surgery has been estimated to be around 2.1-3.1%, being the lumbar region the most prone to infection with a reported incidence of 3.7-6.9%. wound management and the choice of materials used for skin closure can influence the rate of wound-related complications. this work is a retrospective, mono-centric analysis of data collected for surgical site infections (ssis) surveillance in patients with lumbar spinal fusion surgery, the primary outcome is surgical site infections rate in the cohort and its relation to the wound closure method (adhesive strips vs sutures). using a propensity score matching and a non-inferiority analysis the objective was to determined if adhesive strips is not inferior to sutures regarding ssis.

Eligibility criteria:
inclusion criteria: * patients undergoing spinal fusion surgery. * open posterior approach. * surgery involving one or two spinal segments. * patients aged 18 years or older. * skin closure performed using either sutures or adhesive strips. exclusion criteria: * history of previous surgical site infections. * diagnosis of spondylodiscitis. * postoperative complications unrelated to surgical site infections. * deep surgical site infections (a3 classification). * patients undergoing surgeries other than lumbar spinal fusion.

Keywords: lumbar spinal fusion surgery surgical site infections sutures adhesive strips non-inferiority study wound infections superficial wound infections
post-operative pain scores and analgesic requirements after elective inguinal herniorrhaphy

Conditions: Pain; Analgesia; Hernia, Inguinal

Summary: the study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.

the study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery

Eligibility criteria:
inclusion criteria: * subjects having elective surgery with open unilateral inguinal herniorraphy exclusion criteria: * non elective surgery * patients currently on gabapentin therapy * patient hypersensitive to gabapentin surgery * history of alcohol or drug abuse * patients who are pregnant or who are nursing

Keywords: analgesia requirement and post operative pain
open label placebo in the treatment of low back pain

Conditions: Chronic Low Back Pain

Summary: patients will be randomized to receive open-label (honestly described placebo) immediately at baseline or be eligible to receive the open-label treatment three weeks after the baseline measurements. therefore all patients will be eligible to receive open-label placebo treatment for their chronic low back pain during the course of the study.

chronic low back pain (clbp) is a debilitating and costly condition that affects 1.2 million portuguese with an estimated cost in the united stated of $50 billion. randomized controlled trials has shown that placebo interventions can dramatically reduce chronic low back pain and its associated disability. generally, it is assumed that response to placebo requires concealment or deception, which presents a dilemma to the clinician. in clinical practice, how can patients benefit from an available, effective and potentially cost-effective intervention without being deceived? this study seeks to determine ethically acceptable open-label placebo treatment (with full informed consent) can lead to meaningful benefits. the primary study will involve 80 patients with clbp who will be randomly assigned to a three-week course of either non-deceptive open-label placebo pills in the context of a persuasive rationale + treatment as usual or to be continued on their treatment-as-usual. primary outcome measures will be pain intensity and symptom bothersomeness on the previous week. additionally, the study will investigate a possible association between the genetic variation of the catechol-o-methyltransferase (comt polymorphisms) with the hypothesized observed placebo effect on clbp patients. participants will be followed for 3 weeks with a mid-point (11 days) visit. patients who receive only usual care for the first three weeks will be eligible to elect a three week course of treatment with open-label placebo after which they will be assessed. this study has been submitted and approved by the following review board: comissão de ética do centro hospitalar de lisboa ocidental (lisbon west hospitals centre's ethical committee) institutional review board.

Eligibility criteria:
inclusion criteria: * male or female * 18 years or older * low back pain complaints for a min. of 3 months exclusion criteria: * use of strong opioid analgesic and/or anticonvulsant medication; * specific causes of back pain namely cancer, fractures and infections; * complicated back problems (e.g. prior back surgery); * conditions making treatment difficult (e.g. paralysis, psychoses); * conditions that might confound treatment effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis); * concurrent care from other providers; * conditions that affect safety of patient (e.g. pregnancy); * concurrent medical legal issues.

Keywords: chronic low back pain open-label placebo